Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lapatinib · 2 trials · 1 indication
PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) Version (v1.1), or death from any cause during the study, whichever occurs first. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeter (mm) taking as reference the smallest sum during the study including baseline or the appearance of one or more new lesions. Tumor assessments will be performed with computed tomography (CT) or magnetic resonance imaging (MRI) scans.
PD was assessed by an IRC using modified Response Evaluation Criteria in Solid Tumors (RECIST). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as target lesions (TLs) and recorded at baseline. TLs should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements either by imaging or clinically. A sum of the longest diameter for all TLs was calculated as baseline sum longest diameter (SLD). All other lesions (or sites of disease) should be identified as non-TLs and recorded at baseline. PD for TLs was defined as greater than or equal to (\>/=) 20 percent (%) increase in SLD, taking as reference smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of Participants with PD by IRC or death from any cause was reported.
Tumor response was assessed by an IRC according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs (on the basis of their size and their suitability for accurate repeated measurements either by imaging or clinically) and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. All other lesions were identified as non-TLs and recorded at baseline. PD for TLs: \>/= 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS: time from randomization to first documented PD by IRC or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.
The percentage of participants who died from any cause was reported. The results are reported from second interim analysis, which deemed to be the confirmatory.
OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results are reported from second interim analysis, which deemed to be the confirmatory.
The percentage of participants who died from any cause was reported. The results reported are from the final analysis. The final analysis is descriptive.
OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results reported are from the final analysis. The final analysis is descriptive.
1 year survival was defined as the percentage of participants alive 1 year after starting treatment. The results reported are from the final analysis.
2 year survival was defined as the percentage of participants alive 2 years after starting treatment. The results reported are from the final analysis.
| Arm | Type | Description |
|---|---|---|
| Trastuzumab Emtansine | EXPERIMENTAL | Participants with HER2-positive, unresectable LABC or MBC who have experienced disease progression after treatment with trastuzumab and a taxane will be treated with trastuzumab emtansine. Participants may continue to receive study treatment until disease progression (as assessed by the investigator), unmanageable toxicity, or study termination by the Sponsor. |
| Control (lapatinib + capecitabine) | ACTIVE_COMPARATOR | Participants with HER2-positive, unresectable LABC or MBC who have experienced disease progression after treatment with trastuzumab and a taxane will be treated with lapatinib plus capecitabine. Participants may continue to receive study treatment until disease progression (as assessed by the investigator), unmanageable toxicity, or study termination by the Sponsor. |
| Lapatinib + Capecitabine | ACTIVE_COMPARATOR | Participants will receive lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 milligrams per square meter (mg/m\^2) orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Eligible participants will cross over to receive trastuzumab emtansine if second interim analysis demonstrates statistically significant overall survival benefit in favor of trastuzumab emtansine. |
| Name | Type | Description |
|---|---|---|
| Trastuzumab Emtansine | BIOLOGICAL | Trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) was administered intravenously on Day 1 of each 21-day cycle. |
| Lapatinib | DRUG | Lapatinib 1250 mg was administered orally once per day of each 21-day cycle. |
| Capecitabine | DRUG | Capecitabine 1000 milligrams per square meter (mg/m\^2) was administered orally twice daily on Days 1-14 of each 21-day cycle. |
Inclusion Criteria: * Aged \>/= 18 years * Prospective centrally assessed HER2-positive disease (i.e., immunohistochemistry \[IHC\] 3+ and/or gene amplified \[HER2 to Chromosome 17 \[CEP 17\] ratio \>/= 2\]) by in situ hybridization (ISH) through use of archival paraffin-embedded tumor tissue * His...
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Lapatinib is a small molecule being studied for the treatment of HER2-positive locally advanced or metastatic breast cancer. It is administered in combination with capecitabine in clinical trials. Lapatinib is an investigational drug and is not approved for this use.
Lapatinib targets the HER2 receptor, which is overexpressed in certain breast cancers. By inhibiting HER2 signaling, it aims to slow or stop the growth of cancer cells. This mechanism is being evaluated in clinical trials for HER2-positive breast cancer.
Lapatinib is being developed by Roche Holding AG, a company traded on the OTC market under the ticker RHHBY. Roche is conducting clinical trials to evaluate the drug's safety and efficacy in breast cancer.
Lapatinib is in Phase 3 clinical development. Two Phase 3 trials have been completed, with a total of 1,342 participants enrolled. The drug remains investigational and has not been approved by regulatory authorities.
Lapatinib has been studied in two completed Phase 3 trials. NCT00829166 compared trastuzumab emtansine versus capecitabine plus lapatinib in 991 participants with HER2-positive locally advanced or metastatic breast cancer. NCT03084939 evaluated trastuzumab emtansine in 351 Chinese participants with the same condition.
Lapatinib is the generic name for the drug also known as Tykerb. In clinical trials, it is referred to as lapatinib, and it is being studied in combination with capecitabine for HER2-positive breast cancer.